Aurobindo Pharma, Glenmark recall products in US
Aurobindo Pharma USA Inc, a subsidiary of Hyderabad-based drug maker, is recalling over 1 lakh bottles of Cinacalcet tablets in multiple strengths.
The New Jersey-based firm is recalling the product due to «GMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit,» the US health regulator said.
The company initiated the Class II recall on November 7 this year. Cinacalcet tablets are used to treat hyperparathyroidism.
Similarly, a US-based subsidiary of Glenmark Pharmaceuticals is recalling around 90,000 bottles of Diltiazem Hydrochloride extended-release capsules (multiple strengths) in the US market.
New Jersey-based Glenmark Pharmaceuticals Inc, USA is recalling the affected lot of Diltiazem Hydrochloride extended-release capsules due to «cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit», the US health regulator stated.
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